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Top Adding - Campaign 2008 - Occasional Commentary
This piece of occasional commentary on the 2008 campaign focuses on the race for the Democratic Party’s nomination for President. At this time, polling shows Senator Hillary Clinton with a narrowing lead. The narrowing lead reasonably reflects that she is the favorite but that the potential exists for someone else to win the nomination.
My assessment of the leading can
My assessment of the leading can
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
didates follows:
Senator Hillary Clinton:
She is currently suffering somewhat on account of her vote to authorize the war in Iraq. Her base feels that she voted "wrong" on this issue. To date, she has chosen not to appease them with any apologies for her vote. While such a course can be risky in the near-term, she can later use her unapologetic stance to highli
Senator Hillary Clinton:
She is currently suffering somewhat on account of her vote to authorize the war in Iraq. Her base feels that she voted "wrong" on this issue. To date, she has chosen not to appease them with any apologies for her vote. While such a course can be risky in the near-term, she can later use her unapologetic stance to highli
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ht her capacity to provide strong, principled leadership. A lack of differentiation from the other candidates and a sense of “staleness” in which she is an “old” political face at a time when the nation is increasingly searching for a “fresh” one are also dogging her campaign. However, her candidacy is not doomed.
First, the odds she faces are less formidable than thos
First, the odds she faces are less formidable than thos
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e her husband faced in 1992. Then, issues concerning marital infidelity and allegations that he strategically pursued graduate education to avoid the Vietnam draft loomed large over his campaign.
Second, there is ample time for her to differentiate herself. If she can demonstrate that she possesses experience, strong leadership skills, clear positions on the major issu
Second, there is ample time for her to differentiate herself. If she can demonstrate that she possesses experience, strong leadership skills, clear positions on the major issu
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s, and a capacity to listen to the people she will gain votes. On the Iraq war, she will assert that her current positions are realistic given the present circumstances. On the issue of healthcare reform, she will argue that her instincts were right (i.e., almost 50 million Americans are presently uninsured, health costs are rising faster than inflation, and the employe
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
r-centered model now in place is eroding) and that she now has workable models from reform efforts in California, Vermont, Massachusetts, etc., along with lessons learned from her past effort to do a better job on an important issue. Her past approach to health care reform might did not sell very well to the general public, but it wasn't unpopular with the Democratic Pa
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
ty. Her immediate task is winning the Democratic Party's nomination, so her overall effort toward that end won’t hurt her.
Third, she has the financial resources to mount a vigorous campaign. Money will make it possible for her to reach prospective supporters on a nationwide basis. Fourth, she has access to her husband, President Bill Clinton. Political/ideological di
Third, she has the financial resources to mount a vigorous campaign. Money will make it possible for her to reach prospective supporters on a nationwide basis. Fourth, she has access to her husband, President Bill Clinton. Political/ideological di
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
fferences many might have with respect to his policies notwithstanding, he offers access to a wealth of experience and contacts that others don't have. As a result, she will have the political contacts to put together strong campaign and policy teams.
All said, she probably has the best odds of winning the nomination, but those odds are only a little better than those
All said, she probably has the best odds of winning the nomination, but those odds are only a little better than those
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
f Senator Obama. She will not score a decisive victory in the primary process. The race for the nomination will likely be fairly close and extended.
Senator Barack Obama:
Senator Obama is widely perceived as a "fresh face" in national politics and has run a campaign that has emphasized inclusiveness. He is perhaps the most charismatic leader in the Democratic
Senator Barack Obama:
Senator Obama is widely perceived as a "fresh face" in national politics and has run a campaign that has emphasized inclusiveness. He is perhaps the most charismatic leader in the Democratic
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
Party's current field of candidates. Those attributes have contributed to his raising nearly as much money as Senator Clinton. A strong start in the primaries could allow him to eclipse Senator Clinton in his fundraising.
His inclusiveness could be an especially powerful attribute at a time when the nation is deeply and severely divided. This could allow him to make "e
His inclusiveness could be an especially powerful attribute at a time when the nation is deeply and severely divided. This could allow him to make "e
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ectability" in the general election a potent selling point. In contrast, to his image as an inclusive leader, polling data shows that Senator Clinton remains a relatively divisive figure, especially outside the Democratic Party.
Furthermore, among the Democratic Party's base, Senator Obama's initial instincts on the Iraq war are viewed as having been "correct" from the
Furthermore, among the Democratic Party's base, Senator Obama's initial instincts on the Iraq war are viewed as having been "correct" from the
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
start. He'll need to be careful to avoid being painted as a "Moveon.org" candidate who is out of the mainstream to maintain the theme of "electability" in the general election. This challenge is feasible, as an anti-Iraq War candidate need not be seen as one who is out of the mainstream or opposed to waging a strong fight in the ideological struggle with radical Islami
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ts.
His biggest drawback is his lack of experience, particularly in the realm of foreign affairs. He will need to address this issue, as Americans are likely to seek candidates who display a reasonable understanding of foreign affairs. According to Bob Woodward’s State of Denial, then Texas Governor George Bush's knowledge of foreign affairs was almost non-exist
His biggest drawback is his lack of experience, particularly in the realm of foreign affairs. He will need to address this issue, as Americans are likely to seek candidates who display a reasonable understanding of foreign affairs. According to Bob Woodward’s State of Denial, then Texas Governor George Bush's knowledge of foreign affairs was almost non-exist
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ent, even after he had received the Republican Party's nomination for the Presidency. Today, with big foreign affairs challenges confronting the nation, a candidate will need to possess credible understanding of foreign affairs issues. Senator Obama is likely a future nominee for President. He has a chance at winning the 2008 nomination, but will need some luck to do so
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
Senator John Edwards:
Senator Edwards is attempting to position himself as the "ideas" candidate, offering policy solutions for an increasingly broad range of issues. Public concern over his wife's health and the possibility that his offering a large number of policy solutions could inadvertently “position” him as being unfocused on the nation’s biggest issue
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
s could diminish his chances. He will likely fade during primary season.
Governor Bill Richardson:
Governor Richardson has strong credentials and demonstrated experience, especially with regard to trade and diplomacy. He can make the case that he is in the best position to rebuild currently frayed U.S. ties with key NATO partners and the world's leading states,
Governor Bill Richardson:
Governor Richardson has strong credentials and demonstrated experience, especially with regard to trade and diplomacy. He can make the case that he is in the best position to rebuild currently frayed U.S. ties with key NATO partners and the world's leading states,
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
restore legitimacy to U.S. foreign policy, and reintroduce diplomacy to the center of overall American foreign policy through his experience, relationships and commitment to pragmatic Realism. However, the key selling point will need to be his relationships.
Considering that the neoconservative approach to foreign policy has been widely discredited, most, if not all ca
Considering that the neoconservative approach to foreign policy has been widely discredited, most, if not all ca
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ndidates, from both the Democratic and Republican Parties will likely offer some variation of the Pragmatic Realist approach to foreign policy. Such an approach entails realpolitik with a dose of idealism; a focus on the national interest; diplomacy at the center of U.S. foreign policy; use of military power only to address credible and imminent threats to critical U.S.
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
interests; and, reliance on overwhelming military power for any engagements. His familiarity with energy issues could be another advantage. However, he is not exceptionally charismatic and is likely to be viewed more as a potential senior diplomat (e.g., Secretary of State) than President. He probably will not last through the primary season.
Should Senator Obama recei
Should Senator Obama recei
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ve the Democratic Party's nomination, he would do extremely well to choose Governor Richardson as his running mate. Governor Richardson would immediately provide the experience that Senator Obama currently lacks. In terms of general election prospects, an Obama-Richardson ticket would probably offer the Democratic Party its strongest prospects of winning the White House
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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